Position Summary:
* The validation engineer shall be responsible for creating and executing validation documentation and coordinating validation activities for moulding, assembly, testing equipment, computerized systems and facilities within the quality management system.
Key Responsibilities and End Results:
(Essential responsibilities include but are not limited to the following):
* Write the necessary validation plans, protocols, reports & amendments of the Quality Management System ensuring compliance with the latest Regulatory Agencies (HPRA, FDA) directives / requirements within the Medical Device and Pharma Sector.
* Generate applicable quality documentation in conjunction with validation activities.
* Liaise within a cross functional team, to provide and drive validation inputs and initiatives into the overall operational activities of the company.
* Liaise with external vendors for validation plans and requirements.
* Development of validation projects, master validation plans.
* Support the implementation of Company Policies and GMP.
* Support all company safety and quality programs and initiatives.
* Ensure ongoing compliance with GMP in all practices, recording of events and processes.
* Ensure compliance with all learnings from all GMP training events.
* Perform and generate risk assessment documents for regulated processes within the scope of the QMS.
* Participate and drive quality GMP audits.
* Knowledge and use of LEAN 6 sigma tools for problem solution.
* Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Job Specifications:
The minimum education and experience required to perform this job competently.
* Degree in Engineering/Science discipline.
* 3 to 5 years' experience in a Validation or Quality engineering role.
* Strong working knowledge of process validation and capability. Experience in method validation and process characterization is an advantage.
Skills/Attributes:
* Strong working knowledge of validation and quality principles and practices with key emphasis on EudraLex, ISO13485, ISO14644, GAMP5 and FDA Pharma and medical devices regulations.
* Ability to work in a cross functional team environment, with excellent initiative, decision-making and drive for achieving results.
* Excellent technical report writing, time management, computer & presentation skills.
* Excellent interpersonal and communication skills.
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